PrimoCut

FDA UDI

Class I (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name: PrimoCut FDA UDI
Generic Name: Side-notch biopsy gun handpiece/needle FDA UDI
Device Name: PrimoCut 18G (1,2) x 200mm sterile FDA UDI
Model / Reference: 415S120200 FDA UDI
Description: PrimoCut 18G (1,2) x 200mm sterile FDA UDI

Identifiers

Catalog Number: 415S120200 FDA UDI
Primary DI / UDI-DI: 04048223127001 FDA UDI
510(k) Number: K080674 FDA UDI
FDA Product Code: MJG FDA UDI
GMDN Term: Side-notch biopsy gun handpiece/needle FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Side-notch biopsy gun handpiece/needle

PrimoCut by Pajunk GmbH Medizintechnologie — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Side-notch biopsy gun handpiece/needle.

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M-Biopsy — Mermaid Medical A/S · Class II
MONOPTY — Bard Peripheral Vascular · Class II
M-Biopsy — Mermaid Medical A/S · Class II
TOP CUT — H.S. HOSPITAL SERVICE SPA · Class II
M-Biopsy — Mermaid Medical A/S · Class II

Cleared under the same submission

K080674 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Pajunk GmbH Medizintechnologie

Sources (1)

FDA UDI 1a2ff57c-ef8c-4857-b764-b001176287fe 37 fields · synced May 30, 2026